Cleared Special

K161817 - Tina-quant Cystatin C Gen.2

K161817 is an FDA 510(k) clearance for Tina-quant Cystatin C Gen.2, manufactured by Roche Diagnostics Operations (Rdo). The device is a Class 2 Chemistry device with product code NDY cleared through the Special 510(k) pathway after a 26-day FDA review.

K161817 · Roche Diagnostics Operations (Rdo) · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
26d
Days
Class 2
Risk

K161817 is an FDA 510(k) clearance for the Tina-quant Cystatin C Gen.2. Classified as Test, Cystatin C (product code NDY), Class II - Special Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on July 27, 2016 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161817

510(k) Number K161817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2016
Decision Date July 27, 2016
Days to Decision 26 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

NDY Device Classification - Class 2, Special Controls

Product Code NDY Test, Cystatin C
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NDY Test, Cystatin C

All 21
Devices cleared under the same product code (NDY) and FDA review panel - the closest regulatory comparables to K161817.
Cystatin C
K242585 · SENTINEL CH. SpA · May 2025
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082 · Siemens Healthcare Diagnostics, Inc. · May 2018
N Latex Cystatin C
K171072 · Siemens Healthcare Diagnostics Products GmbH · May 2017
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
K141143 · Roche Diagnostics · Jul 2014
DIAZYME CYSTATIN C POC TEST KIT
K111664 · Diazyme Laboratories · Mar 2012
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · Kamiya Biomedical Co. · Sep 2010
K161817 · Tina-quant Cystatin C Gen.2
Download PDF FDA Summary Roche Diagnostics Ope…